Breast CancerCHINCT02566109

Community Hospital Identification of High CV Risk Patients During Cancer Treatment

A study testing Fast MRI in people with Breast Cancer, run by Wake Forest University Health Sciences at 1 site in United States.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record

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Trial summary

Who is it for?: Ages 21 years and older
Conditions the study is for: Breast Cancer
What is being tested?: Fast MRI
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 6 participants
Where: 1 siteUnited States
Study dates: 25 Feb 2016to 4 Oct 2017
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 21 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Newly diagnosed Stage I-III breast cancer (including inflammatory and newly diagnosed recurrent breast cancer) or lymphoma with a > 2 year life expectancy
Scheduled to receive chemotherapy with an Anthracycline (doxorubicin or epirubicin)
= or > 21 years of age
Prior cancers allowed if no evidence of disease
ECOG 0 or 1
Enrollment in NCI Protocol #: WF 98213. Patients must receive Fast MRI and 3D ECHO along with Baseline (98213) MRI prior to first chemotherapy treatment.

Who cannot join

Patients with ferromagnetic cerebral aneurysm clips or other intraorbital/intracranial metal; pacemakers, defibrillators, functioning neurostimulator devices or other implanted electronic devices.
Most breast tissue expanders are not allowed. (If uncertain, inform the MRI tech to confirm eligibility status.)
Unable to provide informed consent
Symptomatic Claustrophobia
Pregnant or breasting feeding. Due to unknown risks and potential harm to the unborn fetus a negative serum pregnancy test within 10 days prior to registration is required in patients with child-bearing potential. For this reason patients of child-bearing potential must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence (not having sex), oral contraceptives, intrauterine device (IUD), DeProvera, tubal ligation, or vasectomy of the partner (with confirmed negative sperm counts) in a monogamous relationship (same partner). An acceptable, although less reliable method involves the careful use of condoms and spermicidal foam or gel and/or cervical cap or sponge prior to study entry and for the duration of study participation. Should a woman become pregnant or suspect she is pregnant while participating in this study, she should inform her study physician immediately.

Trial locations and contacts

1 site in 1 country.

United States1 site

Wake Forest School of Medicine
Winston-Salem, North Carolina, 27157

Other trials in United States

About this study

Official title: Community Hospital Identification of High CV Risk Patients During Cancer Treatment (CHI)

The overall of this proposal is to test in community hospitals the utility of a 10-min magnetic resonance imaging (MRI) scan protocol combined with proprietary image analysis algorithms for detecting early cardiovascular (CV) injury during receipt of chemotherapy for breast cancer (BrC) and lymphoma. This technology provides health-care delivery systems with a time-efficient method to identify those at risk of a future CV event so that prevention can be implemented to prolong survival and reduce morbidity in cancer survivors.

Read the detailed description

While recent research indicates that conventional MRI, advanced echocardiography (global longitudinal strain and 3D) and serum biomarkers can detect CV injury early after receipt of Chemotherapy, these methods require lengthy and difficult examinations that are not routinely executed in community hospitals where the majority of patients with BrC \& lymphoma are treated. Yet, 1-month deteriorations in traditional 45-min MRI measures are known to forecast 6-month subclinical deteriorations in left ventricular ejection fraction (LVEF) that are associated with CV events. At the same time, new observational data indicate therapy with HMG-CoA reductase inhibitors/statins administered early during receipt of Chemotherapy may prevent subsequent cardiac dysfunction and CV events. Our MRI fast scanning techniques remedy these community hospital implementation obstacles.

In this proposal, the investigators propose to test the utility of these fast scans within an existing funded randomized clinical trial R01HL118740 of generic atorvastatin that is researching methods to prevent cardiotoxicity in patients treated with Chemotherapy for BrC and lymphoma (taking advantage of significant existing clinical trial resources). This study allows us to address our over-arching goal: to determine the optimal implementation (alone or in combination with other tests) of our proprietary MRI processes for forecasting CV injury in patients treated with Chemotherapy in community hospitals through performance of a Phase II comparative effectiveness study within an ongoing clinical trial.

Conditions: Breast Cancer
Being tested: Fast MRI
Medical subject headings: Breast Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Fast MRIDiagnostic test
The fast MRI is a 10 minute MRI scan that will be used to determine if cardiovascular injury can be detected early while patients are receiving chemotherapy treatment.

Study groups in NCT02566109
Study group	Role	What they receive
Fast MRI	Other	All patients who agree to participate in this study will have a 10 minute fast MRI scan and Baseline and 6 month time periods. The fast MRI will be used to determine if cardiovascular injury can be detected early while patients are receiving chemotherapy treatment. Receives: Diagnostic Test: Fast MRI

What is being measured

The primary outcome is the main question the study is designed to answer.

Left Ventricular Ejection Fraction (LVEF) at Baseline, 2 Month Using Fast MRI, and 6 Months
To compare baseline, 2-month (using Fast MRI), and 6 month measures in left ventricular (LV) ejection fraction
Measured: Baseline, 2 months, and 6 months
End Diastolic Volume (EDV) at Baseline, 2 Month, and 6 Months
To compare baseline, 2-month (using Fast MRI), and 6 month measures in end Diastolic Volume (EDV)
Measured: Baseline, 2 months, and 6 months
End Systolic Volume (ESV) at Baseline, 2 Month, and 6 Months
To compare baseline, 2-month (using Fast MRI), and 6 month measures in end Systolic Volume (ESV)
Measured: Baseline, 2 months, and 6 months
Pulse Wave Velocity (PWV) at Baseline and 6 Months
To compare baseline and 6 month measures in pulse wave velocity (PWV)
Measured: Baseline and 6 months

Secondary outcomes (3)

Left Ventricular Ejection Fraction (LVEF): Comparison of Magnetic Resonance Imaging (MRI) With Echocardiogram (ECHO) at Baseline
To compare Magnetic Resonance Imaging (MRI) metric of Left Ventricular Ejection Fraction (LVEF) with Echocardiogram (ECHO) at baseline
Measured: Baseline
End Diastolic Volume (EDV): Compare Magnetic Resonance Imaging (MRI) With Echocardiogram (ECHO) at Baseline
To compare magnetic resonance imaging (MRI) metric of End Diastolic Volume (EDV) with echocardiogram (ECHO) at baseline
Measured: Baseline
End Systolic Volume (ESV): Compare Magnetic Resonance Imaging (MRI) With Echocardiogram (ECHO) at Baseline
To compare magnetic resonance imaging (MRI) metric of End Systolic Volume (ESV) with echocardiogram (ECHO) at baseline
Measured: Baseline

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

25 Feb 20164 Oct 2017

First posted2 Oct 2015 (estimated)
Study start25 Feb 2016
Primary completion4 Oct 2017
Study completion4 Oct 2017

Why it stopped: Funding Issues

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Breast CancerStudies of the same condition, open and under way.
More trials run by Wake Forest University Health SciencesThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Supportive care
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrolment: 6 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02566109
Sponsor's protocol ID: IRB00032416
Other IDs: WF-01115
Acronym: CHI
Status last verified: Apr 2019
First submitted: 28 Sep 2015
Last updated: 8 May 2019
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes
FDA-regulated drug: No
FDA-regulated device: Yes
Individual data sharing: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Study at a glance

From the registry record, last updated by the sponsor on 8 May 2019. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Community Hospital Identification of High CV Risk Patients During Cancer Treatment (CHI)
ClinicalTrials.gov ID: NCT02566109
Acronym / sponsor ID: CHI / IRB00032416
Conditions: Breast Cancer
Study type: Interventional
Recruitment status: TerminatedReason stopped: Funding Issues
Enrolment: 6 participants (actual)
Lead sponsor: Wake Forest University Health SciencesUniversity, hospital or other
Study start: 25 Feb 2016 (actual)
Primary completion: 4 Oct 2017 (actual)
Study completion: 4 Oct 2017 (actual)
First posted: 2 Oct 2015 (estimated)
Results: Posted 3 Apr 2019

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Supportive care
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
Fast MRI	Other	Diagnostic Test: Fast MRIAll patients who agree to participate in this study will have a 10 minute fast MRI scan and Baseline and 6 month time periods. The fast MRI will be used to determine if cardiovascular injury can be detected early while patients are receiving chemotherapy treatment.

Who may qualify

Ages: 21 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (6 listed)

Newly diagnosed Stage I-III breast cancer (including inflammatory and newly diagnosed recurrent breast cancer) or lymphoma with a > 2 year life expectancy
Scheduled to receive chemotherapy with an Anthracycline (doxorubicin or epirubicin)
= or > 21 years of age
Prior cancers allowed if no evidence of disease
ECOG 0 or 1

Key exclusion criteria (5 listed)

Patients with ferromagnetic cerebral aneurysm clips or other intraorbital/intracranial metal; pacemakers, defibrillators, functioning neurostimulator devices or other implanted electronic devices.
Most breast tissue expanders are not allowed. (If uncertain, inform the MRI tech to confirm eligibility status.)
Unable to provide informed consent
Symptomatic Claustrophobia
Pregnant or breasting feeding. Due to unknown risks and potential harm to the unborn fetus a negative serum pregnancy test within 10 days prior to registration is required in patients with child-bearing potential. For this reason patients of child-bearing potential must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence (not having sex), oral contraceptives, intrauterine device (IUD), DeProvera, tubal ligation, or vasectomy of the partner (with confirmed negative sperm counts) in a monogamous relationship (same partner). An acceptable, although less reliable method involves the careful use of condoms and spermicidal foam or gel and/or cervical cap or sponge prior to study entry and for the duration of study participation. Should a woman become pregnant or suspect she is pregnant while participating in this study, she should inform her study physician immediately.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Fast MRIThe fast MRI is a 10 minute MRI scan that will be used to determine if cardiovascular injury can be detected early while patients are receiving chemotherapy treatment.	Diagnostic test	Fast MRI

Primary outcome

Left Ventricular Ejection Fraction (LVEF) at Baseline, 2 Month Using Fast MRI, and 6 Months
Time frame: Baseline, 2 months, and 6 months
To compare baseline, 2-month (using Fast MRI), and 6 month measures in left ventricular (LV) ejection fraction
End Diastolic Volume (EDV) at Baseline, 2 Month, and 6 Months
Time frame: Baseline, 2 months, and 6 months
To compare baseline, 2-month (using Fast MRI), and 6 month measures in end Diastolic Volume (EDV)
End Systolic Volume (ESV) at Baseline, 2 Month, and 6 Months
Time frame: Baseline, 2 months, and 6 months
To compare baseline, 2-month (using Fast MRI), and 6 month measures in end Systolic Volume (ESV)
Pulse Wave Velocity (PWV) at Baseline and 6 Months
Time frame: Baseline and 6 months
To compare baseline and 6 month measures in pulse wave velocity (PWV)

3 secondary outcomes

Left Ventricular Ejection Fraction (LVEF): Comparison of Magnetic Resonance Imaging (MRI) With Echocardiogram (ECHO) at Baseline
Time frame: Baseline
End Diastolic Volume (EDV): Compare Magnetic Resonance Imaging (MRI) With Echocardiogram (ECHO) at Baseline
Time frame: Baseline
End Systolic Volume (ESV): Compare Magnetic Resonance Imaging (MRI) With Echocardiogram (ECHO) at Baseline
Time frame: Baseline

Results and safety

Results posted to the registry on 3 Apr 2019, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Fast MRI	6	5

Primary outcome: Left Ventricular Ejection Fraction (LVEF) at Baseline, 2 Month Using Fast MRI, and 6 Months

Time frame: Baseline, 2 months, and 6 months. Mean (Standard Deviation). Unit: percentage of fluid ejected

Measure	Fast MRI n = 5
2 months FAST MRI	56.67 (4.71)
6 months	58.69 (3.28)

Fast MRI: Pearson Correlation Coefficient: -0.57472, p = 0.6102, Pearson Correlation Coefficient
Fast MRI: Pearson Correlation Coefficient: 0.25733, p = 0.8343, Peason Correlation Coefficient

Population analysed: Only 5 received MRI at baseline, 4 at 2 months using Fast MRI, and 3 at 6 months.

Primary outcome: End Diastolic Volume (EDV) at Baseline, 2 Month, and 6 Months

Time frame: Baseline, 2 months, and 6 months. Mean (Standard Deviation). Unit: mL

Measure	Fast MRI n = 5
2 months FAST MRI	126.07 (32.36)
6 months	130.20 (44.52)

Fast MRI: Pearson Correlation Coefficient: -0.09487, p = 0.9395, Pearson Correlation Coefficient
Fast MRI: Pearson Correlation Coefficient: 0.97287, p = 0.1486, Pearson Correlation Coefficient

Population analysed: Only 5 received MRI at baseline, 4 at 2 months using Fast MRI, and 3 at 6 months.

Primary outcome: End Systolic Volume (ESV) at Baseline, 2 Month, and 6 Months

Time frame: Baseline, 2 months, and 6 months. Mean (Standard Deviation). Unit: mL

Measure	Fast MRI n = 5
2 months FAST MRI	54.72 (14.52)
6 months	54.73 (23.11)

Fast MRI: Pearson Correlation Coefficient: 0.10327, p = 0.9341, Pearson Correlation Coefficient
Fast MRI: Pearson Correlation Coefficient: 0.99696, p = 0.0497, Pearson Correlation Coefficient

Population analysed: Only 5 received MRI at baseline, 4 at 2 months using Fast MRI, and 3 at 6 months.

Primary outcome: Pulse Wave Velocity (PWV) at Baseline and 6 Months

Time frame: Baseline and 6 months. Mean (Standard Deviation). Unit: Meters/sec

Measure	Fast MRI n = 5
Baseline	4.74 (1.75)
6 months	4.07 (1.70)

Fast MRI: Pearson Correlation Coefficient: 0.98432, p = 0.1129, Pearson Correlation Coefficient

Population analysed: Only 5 received MRI at baseline and 3 at 6 months.

3 secondary outcomes are reported in the full results.

Adverse events

Time frame: From time of signed informed consent to 30 days post study completion for each participant. Study completion was approximately 6 months.. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Fast MRI	0 of 6 (0%)	1 of 6 (16.7%)	0 of 6

Limitations and caveats (from the sponsor): Early termination leading to small number of subject analyzed.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 8 May 2019.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Individual participant dataSharing planned: No

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Gregory Hundley, MD principal investigator

Wake Forest University Health Sciences

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing Fast MRI in people with Breast Cancer, run by Wake Forest University Health Sciences at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 8 May 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 3 Apr 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Left Ventricular Ejection Fraction (LVEF) at Baseline, 2 Month Using Fast MRI, and 6 Months (time frame: Baseline, 2 months, and 6 months). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02566109.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 May 2019.